• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MEXICO EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number EUP2515X
Device Problems Burst Container or Vessel (1074); Packaging Problem (3007); Physical Resistance/Sticking (4012)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
One euphora rx balloon catheter was intended to be used to treat a non remarkable lesion. There was no damage noted to the device packaging. There were no issues noted when removing the device from the hoop. The device was inspected with no issues. Negative prep was not performed. The lesion was not pre-dilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device and excessive force was not used. It was reported that the balloon burst upon inflation inside the lesion. No patient injury is reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product analysis summary: the balloon returned with no blood visible in the balloon and inflation lumen. The balloon failed negative prep. On pressurisation of the device, a leak was observed on the balloon working length. The balloon failed to maintain pressure. Upon visual inspection of the device, there was a longitudinal tear on the entire working length of the balloon material. The balloon material was jagged and uneven at the tear site. Lead in scratches were evident proximal to the tear site. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEUPHORA RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7668988
MDR Text Key113777230
Report Number9612164-2018-01654
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K143480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/16/2019
Device Catalogue NumberEUP2515X
Device Lot Number213843563
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-